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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01516892




Registration number
NCT01516892
Ethics application status
Date submitted
20/01/2012
Date registered
25/01/2012
Date last updated
6/01/2017

Titles & IDs
Public title
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
Scientific title
Secondary ID [1] 0 0
The COMPEL Study
Secondary ID [2] 0 0
GMA-BTX-CM-10-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - onabotulinumtoxinA

Experimental: BOTOX® - Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.


Other interventions: onabotulinumtoxinA
Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Frequency of Headache Days
Timepoint [1] 0 0
Baseline, Week 108
Secondary outcome [1] 0 0
Change From Baseline in the Frequency of Headache Days
Timepoint [1] 0 0
Baseline, Week 60
Secondary outcome [2] 0 0
Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score
Timepoint [2] 0 0
Baseline, Week 60, Week 108

Eligibility
Key inclusion criteria
- Diagnosis of chronic migraine (=15 days per month with headache lasting 4 hours a day
or longer)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral
sclerosis

- Headache attributed to another disorder

- Infection or skin disorder at injection sites

- Previous treatment with botulinum toxin of any serotype for any reason

- Anticipated need for botulinum toxin of any type for any reason during the course of
the study

- Previous participation in any botulinum toxin clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
716
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Dr. Joseph Frasca - Adelaide
Recruitment hospital [2] 0 0
Dr. Con Yiannikas - Burwood
Recruitment hospital [3] 0 0
Associate Professor Richard Stark - Melbourne
Recruitment hospital [4] 0 0
Richmmond Neurology - Richmond
Recruitment hospital [5] 0 0
Associate Professor John O'Sullivan - Spring Hill
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [2] 0 0
NSW 2134 - Burwood
Recruitment postcode(s) [3] 0 0
VIC 3000 - Melbourne
Recruitment postcode(s) [4] 0 0
VIC 3051 - Richmond
Recruitment postcode(s) [5] 0 0
QLD 4000 - Spring Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Anyang Gyeonggi-do
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Gyeonggi-Do
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This open-label study will assess the long-term efficacy, safety, and tolerability of
onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic
migraine.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01516892
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries